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| Name | Class |
|---|---|
| Helse Nord-Trøndelag HF | OTHER |
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This studies aims at testing continuous registration of bioimpedance during hemodialysis and comparing the measurement with extracted liquid.
The purpose is to test the sensitivity and specificity of a new electronic patch in the indication of the relative change in the fluid balance. If possible, the change in hydration level should be quantified. The test is done on patients during hemodialysis. Extracted amount of fluid is used as the primary reference to the bioimpedance measurements, but other references will also be used.
The measurement is made using bioimpedance measured with four electrodes and over a large frequency spectrum. Impedance measurements are made every 20 seconds throughout the test period. The measurement is recorded in a memory (flash) on each patch. At the same time as measuring bioimpedance, the temperature in the patch is recorded.
After completion of the test, the data is transferred to a computer for analysis. As a reference, extracted amount of fluid, weight change, blood samples and clinical evaluation are used.
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of patch performance | Establish sensitivity and specificity of patch performance relative to extracted water, weight change and blood sample results | August - December 2019 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients for hemodialysis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jørn Kværness | Contact | +4795089723 | jorn@modesensors.com |
| Name | Affiliation | Role |
|---|---|---|
| Magnus Nordahl | Mode Sensors AS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levanger Hospital | Recruiting | Levanger | Norway |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 11, 2021 | |
| Reset | Dec 9, 2021 | |
| Release | Dec 13, 2021 | |
| Reset | Mar 4, 2022 | |
| Release | Mar 23, 2022 | |
| Reset | Jul 21, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 11, 2021 | Dec 9, 2021 | |||
| Dec 13, 2021 |
| ID | Term |
|---|---|
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| Mar 4, 2022 |
| Mar 23, 2022 | Jul 21, 2022 |
| D013568 | Pathological Conditions, Signs and Symptoms |